STATIN: Web-based Investigation of Side Effects
STATINWISE
A Series of Randomised Controlled N-of 1 Trials in Patients Who Have Discontinued or Are Considering Discontinuing Statin Use Due to Muscle-related Symptoms to Assess if Atorvastatin Treatment Causes More Muscle Symptoms Than Placebo
1 other identifier
interventional
200
1 country
58
Brief Summary
Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown of muscle tissue) but many patients stop taking statins due to less severe symptoms, such as muscle pain or fatigue. This study aims to determine whether symptoms occurring during statin use are caused by statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin) vs. placebo. Patients will be randomized to alternating treatment blocks of either statin or placebo split into six two-month treatment periods. At the end of each period, patients will be asked to self-report side effects using a website or mobile app.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2016
Typical duration for phase_4
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedAugust 16, 2019
August 1, 2019
2.9 years
May 13, 2016
August 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Muscle Symptoms
Patient reported muscle symptoms (pain, weakness, tenderness, stiffness or cramp).
Every 8 weeks for 12 months in total
Secondary Outcomes (1)
Patient belief of statin effects, medication adherence
at 15 months post randomisation
Study Arms (2)
Atorvastatin 20mg
ACTIVE COMPARATORAtorvastatin to be taken daily in 2 month treatment periods, 3 treatment periods in 12 months
Placebo - Microcrystalline Cellulose
PLACEBO COMPARATORPlacebo to be taken daily in 2 month treatment periods, 3 treatment periods in 12 months
Interventions
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Eligibility Criteria
You may qualify if:
- Adults (aged 16 and over)
- Prescribed statin treatment in the last 3 years
- Stopped OR considering stopping statin treatment due to muscle symptoms
- Provided fully informed consent.
You may not qualify if:
- Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal;
- Have persistent, generalised, unexplained muscle pain (whether associated or not with statin use) and have creatinine kinase (CK) levels greater than 5 times the upper limit of normal
- Any contraindications listed in the IMP SPC
- Should not be using atorvastatin 20mg daily in the opinion of the general practitioner.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Bicester Health Centre
Bicester, OX26 6AT, United Kingdom
Oak Tree Surgery
Bridgend, CF 31 2PQ, United Kingdom
Bromley Common Practice
Bromley, BR2 9GT, United Kingdom
Great Sutton Medical Centre
Chester, CH66 3SP, United Kingdom
Woodlands Practice
Chislehurst, BR7 6DB, United Kingdom
Regent House Surgery
Chorley, PR7 2DH, United Kingdom
Creffield Medical Centre
Colchester, CO2 7GH, United Kingdom
Mattishall & Lenwade Surgeries
Dereham, NR20 4QA, United Kingdom
Conisbrough Group Practice
Doncaster, DN12 3JW, United Kingdom
Scott Practice
Doncaster, DN4 0TG, United Kingdom
Bentley Surgery
Doncaster, DN5 0AT, United Kingdom
Oak Lodge Medical Centre
Edgware, HA8 0AP, United Kingdom
Falkland Surgery
Great Yarmouth, NR31 8RW, United Kingdom
Freshney (Littlefields) Green Primary Care Centre
Grimsby, DN34 4GB, United Kingdom
Bay Medical Group
Heysham, LA3 2LE, United Kingdom
Hoveton and Wroxham Medical Centre
Hoveton, NR12 8DU, United Kingdom
Mathukia's Surgery
Ilford, IG1 2SF, United Kingdom
Station House Surgery
Kendal, LA9 6SA, United Kingdom
Queen Square Medical Practice
Lancaster, LA1 1RP, United Kingdom
Brownlow Health
Liverpool, L69 3GF, United Kingdom
William Harvey Heart Centre
London, EC1M 6BQ, United Kingdom
Tottenham Health Centre
London, N17 8AH, United Kingdom
Hornsey Rise Health Centre
London, N19 3YU, United Kingdom
Keats Medical Practice
London, NW3 1LR, United Kingdom
Hampstead Group Practice
London, NW3 2QU, United Kingdom
Parliament Hill Medical Centre
London, NW5 1TR, United Kingdom
West Hampstead Medical Centre
London, NW6 1TP, United Kingdom
Everglade Medical Practice
London, NW9 5XT, United Kingdom
Vanbrugh Group Practice
London, SE10 9GB, United Kingdom
Hurley Clinic
London, SE11 4HJ, United Kingdom
Albion Street Practice
London, SE16 7JX, United Kingdom
Paxton Green Group Practice
London, SE21 8AU, United Kingdom
Honor Oak Group Practice
London, SE4 2LA, United Kingdom
Open Door Surgery
London, SW12 8EU, United Kingdom
Mayfield Surgery
London, SW15 4AA, United Kingdom
The Exchange Surgery
London, SW16 2ST, United Kingdom
Streatham Common Practice
London, SW16 5LS, United Kingdom
Riverside Medical Practice
London, SW8 2JB, United Kingdom
Watling Medical Centre
London, United Kingdom
Rosedale Surgery
Lowestoft, NR33 8LG, United Kingdom
Mitcham Family Practice
Mitcham, CR4 3HS, United Kingdom
Vale of Neath
Neath, SA11 5AL, United Kingdom
Pendle View Medical Centre
Nelson, BB9 5RZ, United Kingdom
Long Stratton Medical Partnership
Norwich, NR15 2UY, United Kingdom
Clarence Medical Centre
Rhyl, LL18 1DA, United Kingdom
North House Surgery
Ripon, HG4 1HL, United Kingdom
Beechtree Surgery
Selby, YO8 9AJ, United Kingdom
Snaith & Rawcliffe Medical Group (The Marshes Surgery)
Snaith, DN14 9DY, United Kingdom
Kings Road Surgery
Swansea, SA3 4AJ, United Kingdom
Strawberry Place Surgery
Swansea, SA6 7AQ, United Kingdom
School Lane Surgery
Thetford, IP24 2AG, United Kingdom
Brigstock & South Norwood Partnership
Thornton Heath, CR7 7JN, United Kingdom
Village Practice Thornton
Thornton-Cleveleys, FY5 2TZ, United Kingdom
Cleveleys Group Practice
Thornton-Cleveleys, FY5 3LF, United Kingdom
Wallington Family Practice
Wallington, SM6 0HY, United Kingdom
Windermere & Bowness Surgery
Windermere, LA23 2EG, United Kingdom
Hope Family Medical Centre
Wrexham, LL12 9NP, United Kingdom
Jorvik Gillygate Practice
York, YO1 7NP, United Kingdom
Related Publications (1)
Herrett E, Williamson E, Brack K, Beaumont D, Perkins A, Thayne A, Shakur-Still H, Roberts I, Prowse D, Goldacre B, van Staa T, MacDonald TM, Armitage J, Wimborne J, Melrose P, Singh J, Brooks L, Moore M, Hoffman M, Smeeth L; StatinWISE Trial Group. Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials. BMJ. 2021 Feb 24;372:n135. doi: 10.1136/bmj.n135.
PMID: 33627334DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haleema Shakur, RN
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blinded IMP
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 24, 2016
Study Start
September 1, 2016
Primary Completion
August 8, 2019
Study Completion
August 8, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08